NCT06445686

Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.

Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Biosency · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the feasibility of early detection of acute exacerbations of idiopathic pulmonary fibrosis by the remote monitoring of vital signs. The main question the study aims to answer is: Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection? All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.

Detailed description

All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device. To do this, they will be equipped with a Bora Band® connected wristband that measures vital signs at home, and the Bora Box® Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect® data visualization platform. The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband. At the end of the follow-up period, the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations, and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis. Procedure: * Inclusion Visit : 6-minute walk test and prescription of oxygen therapy * Home Installation Visit: installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect® bracelet and Bora Box® Gateway * Follow-up Visit with the Pulmonologist at 6 months (M6): routine examinations, satisfaction questionnaire, and quality of life questionnaire * End of Study Visit with the Pulmonologist at 12 months (M12): routine examinations, satisfaction questionnaire, and quality of life questionnaire. (In case of exacerbation, the follow-up will be extended by 3 months to collect post-exacerbation data.)

Conditions

• Idiopathic Pulmonary Fibrosis

Timeline

• Start date: 2024-06-17
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-06-06
• Last updated: 2024-08-15

Locations

1 site across 1 country: France